Catheter Ablation as the First Line Therapy for Typical Atrial Flutter

NCT00213408 | Terminated Phase 4

• 1 other identifier: 1999/026/HP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates. It has also been shown that ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in quality of life. We sought to evaluate the cost/effectiveness of catheter ablation as the first line therapy in patient suffering from their first symptomatic typical atrial flutter episode. This study is a multicenter trial in which patients with a first symptomatic episode of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic drugs after electrical cardioversion. Clinical examination, quality of life questionnaires,12 leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following randomization.The primary end-point is the absence of recurrence of typical atrial flutter at - and 12 months of follow up. The secondary end points are the cost and the cost/effectiveness ratio of these two approaches.

Conditions

Atrial Flutter

Keywords

Arrhythmia; atrial flutter; catheter ablation

Outcome Measures

Primary Outcomes (1)

• Absence of typical atrial flutter recurrence at 6 and 12 months

Secondary Outcomes (1)

• Cost/effectiveness ratio at 12 months

Interventions

Radiofrequency catheter ablation of typical atrial flutter PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first episode of symptomatic typical atrial flutter
• \> 18 years old

You may not qualify if:

• Prior antiarrhythmic drug treatment for atrial flutter
• History of cavotricuspid isthmus ablation
• Pregnancy
• Hyperthyroidism
• contraindication for anticoagulant therapy
• Life expectancy \< 1 year
• contraindication to catheter ablation or to electrical cardioversion

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU de Rouen

Rouen, Seine Maritime, 76031, France

Location

MeSH Terms

Conditions

Atrial Flutter; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• frederic Anselme, MD, PhD

  Service de Cardiologie, Rouen University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: June 1, 2001
• Study Completion: January 1, 2007
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

FR (1)